12 June 2019 - - US-based biotechnology company Genentech has received positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva (obinutuzumab) for adults with proliferative lupus nephritis, the company said.
Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
The study met its primary endpoint, showing Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.
In addition, Gazyva met key secondary endpoints showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo.
Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with the highest risk of end-stage renal disease and death.
In addition to meeting the primary endpoint, the study's key secondary endpoint, defined as achievement of overall renal response (complete or partial renal response) at one year, was also met.
No new safety signals were observed with Gazyva in the study at the time of this analysis.
The full results from the study will be presented at a future medical meeting.
The Phase II, randomised, double-blind, placebo-controlled, multi-center study, NOBILITY (NCT02550652), compares the safety and efficacy of Gazyva, combined with mycophenolate mofetil or mycophenolic acid and corticosteroids, to placebo, combined with MMF or MPA and corticosteroids, in adult patients with ISN/RPS 2003 Class III or IV proliferative lupus nephritis.
The study enrolled 126 people who were randomised to receive Gazyva or placebo infusions on Days 1, 15, 168, and 182. The primary endpoint was the proportion of participants who achieved a protocol-defined complete renal response at 52 weeks.
Lupus nephritis is a severe and potentially life-threatening disorder of the kidneys. Lupus nephritis is a complication of systemic lupus erythematosus, an autoimmune disease where a person's own immune system attacks healthy cells and organs.
An estimated 1.5m Americans are affected by lupus, with approximately 70% of cases representing SLE.
Up to 60% of people with SLE will develop lupus nephritis, and up to 25 % of people with the condition develop end-stage renal disease.
Lupus nephritis overwhelmingly impacts women, particularly young women of colour.
About 90% of those diagnosed are women, and African-American, Hispanic, Native American and Asian-American women are two to three times more likely than Caucasian women to get lupus.
Currently, there is no cure for lupus or lupus nephritis.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.
Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.